Similarities and differences in the discovery and use of biopharmaceuticals and small-molecule chemotherapeutics

Introduction to Biological and Small Molecule Drug Research and Development: Theory and Case Studies

Volumn , Issue , 2013, Pages 161-203

  Samanen, James ^a,b  

^a James Samanen Consulting LLC   (United States)

^b YourEncore   (United States)

Author keywords

(Abbreviated) New drug application ((A)NDA); Abciximab; Antigenicity; Biologics; Biologics license application (BLA); Biologics Price Competition and Innovation Act (BPCIA); Biomolecules, biomolecular drugs; Biosimilars follow on biologics; Biotechnology; Chemistry, manufacturing and control (CMC); Chimeric Mab; Cytokines; Eptifibatide; Fab; Fc; GlaxoSmithKline (GSK); GPIIB IIA Antagonists; Hatch Waxman Act; Her2 Antagonists; Humanized Mab; Hypersensitivity; Insulin; Investigational new drug application (IND); Lapatinib; Monoclonal antibodies (Mabs); New biological entity (NBE); New chemical entity (NCE); New molecular entity (NME); Peptide drugs; Pharmaceutical Research and Manufacturers of America (PhRMA); Probability of success (POS); Recombinant; Recombinant protein (rDNA); Therapeutic proteins; Thrombopoietin (TPO); Tirofiban; Tissue growth factors; Trastuzumab; Uridine 5' diphospho (UDP) glucuronosyltransferase, US Center for Drugs Biologics Evaluation and Research (CD BER); US Food and Drug Administration (FDA)

Indexed keywords

EID: 84903672035     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-397176-0.00005-4     Document Type: Chapter

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